Sohag university hospitals
Sohag, Egypt
NCT Number: NCT07116369
This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality.
Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Sohag, Egypt
This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.
The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.
Inclusion criteria
include cirrhotic patients with ascites undergoing diagnostic paracentesis.
Exclusion criteria
include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.
Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.
The study will assess whether a combined score (ALBI-Na-Platelet) can improve prediction accuracy. Statistical analysis will involve logistic regression and ROC curve analysis to evaluate the predictive power of the combined parameters.
All participants will provide written informed consent. The study is approved by the Medical Ethics Committee of Sohag University, Faculty of Medicine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 1 week
Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium
Contact information is provided by the study sponsor or research team.
Sohag University
Other
Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .
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